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A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

RECRUITINGPhase 2Sponsored by California Pacific Medical Center Research Institute
Actively Recruiting
PhasePhase 2
SponsorCalifornia Pacific Medical Center Research Institute
Started2021-09-20
Est. completion2024-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05077280

Summary

This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* measurable metastatic uveal melanoma.
* No concomitant therapy.
* Prior PD1 or tebendafesp allowed.
* Performance status 0-1.
* No active Hepatitis B.
* No known HIV infection.
* WBC\>2000, ANC\>1500, Hgb \>8.
* Creatinine \< 3 x ULN.
* AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
* Albumin \>2.9

Exclusion Criteria:

* Liver tumor volume \> 50%.
* Active CNS metastases.
* Pregnancy.
* Prior therapy with Opdualag or relatlimab
* Certain autoimmune diseases.
* Previous liver embolization or radiation.
* Use of systemic steroids

Conditions2

CancerUveal Melanoma

Locations1 site

California Pacific Medical Center Research Institute
San Francisco, California, 94115
Madeline Decker415-600-3613KimB@sutterhealth.org

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